The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®
African Journal of Primary Health Care & Family Medicine
| Field | Value | |
| Title | The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase® | |
| Creator | Matlala, Mafora F. Lubbe, Martha S. Steyn, Hanlie | |
| Description | Background: Spontaneous reporting is regarded as a cornerstone of pharmacovigilance (PV) but presents many limitations, including varying quality and completeness of information, which is essential for causality assessment.Aim: This study aimed to evaluate the completeness of adverse drug reaction (ADR) reports in South Africa based on the vigiGrade completeness score.Setting: The South African Health Products Regulatory Authority (SAHPRA).Methods: A cross-sectional, descriptive study of all reports received by SAHPRA and submitted to VigiBase® in 2017 was conducted. A report with a vigiGrade score 0.8 is considered well-documented.Results: The mean completeness score for the 8438 reports received was 0.456 (s.d. = 0.221). Only 11.3% of reports had a completeness score 0.8. The completeness of reports submitted by consumers professionals did not significantly differ from reports by physicians, pharmacists or other healthcare professionals (d ≤ 0.2). Reports of reactions that resulted in death (M = 0.572, s.e. = 0.007), disability (M = 0.491, s.e. 0.033) or were life threatening (M = 0.474, s.e. = 0.013) had a medium to large practically significant effect (0.5 ≥ d ≤ 0.8) on the completeness score compared with reports of congenital anomaly (M = 0.348, s.e. = 0.089).Conclusion: The completeness of reports submitted by consumers is comparable to those submitted by healthcare professionals. The completeness of reports was low and multiple measures to improve reporting are recommended.Contribution: This study describes the completeness of ADR reports in South Africa and the results can be used to improve training. | |
| Publisher | AOSIS | |
| Date | 2023-01-18 | |
| Identifier | 10.4102/phcfm.v15i1.3659 | |
| Source | African Journal of Primary Health Care & Family Medicine; Vol 15, No 1 (2023); 9 pages 2071-2936 2071-2928 | |
| Language | eng | |
| Relation |
The following web links (URLs) may trigger a file download or direct you to an alternative webpage to gain access to a publication file format of the published article:
https://phcfm.org/index.php/phcfm/article/view/3659/5974
https://phcfm.org/index.php/phcfm/article/view/3659/5978
https://phcfm.org/index.php/phcfm/article/view/3659/5976
https://phcfm.org/index.php/phcfm/article/view/3659/5977
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